August 2013

Transvaginal mesh (TVM) is a mesh implant used to treat damaged vaginal tissues. One condition TVM has been commonly used to treat is called pelvic organ prolapse (POP). POP is characterized by weakening of the tissues that hold the pelvic organs in place, and occurs in 30-50% of women.

An observational study, titled “Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 5-year prospective follow-up study”, conducted by Bernard Jacquetin, et al. and published by The International Urogynecological Association in 2010, evaluated the long term effectiveness of procedures using TVM. More specifically, the purpose of the study was “to assess effectiveness, both anatomical and subjective, and complications for the TVM technique for POP repair.” The evaluations were conducted up to three years after implantation of TVM, with additional future evaluations scheduled at 5 years post-implantation. Subjects included women over the age of 21 treated for either anterior or posterior damage, and having already undergone a hysterectomy to limit confounding factors. Women suffering from uncontrolled diabetes or coagulation disorders were not included in the data set.

Effectiveness of TVM was evaluated based on “prolapse recurrence, defined as a POP-Q Stage II or more…or surgical intervention for recurrence of prolapse.” The data revealed an anatomical success rate of 81.2% three years post-operation; which is not significantly different from the success rate of 81.6% at one year post-implantation.

Some confounding variables in the study include the fact that different cuts of TVM, and different needles, were used depending on the nature of the procedure; therefore, the study technically did not evaluate a “standard” procedure. Ultimately the study concluded that transvaginal mesh, may in fact be a reliable solution for surgical repair of damaged vaginal tissues, stating that “the early positive anatomical findings and positive impact on patients’ quality of life scores are sustained after 3 years. The TVM procedure is associated with a high total reintervention rate (13.3%) but the low re-intervention rate for prolapse (3.3%) suggests that a total vaginal mesh seems to lead to a stable repair of the pelvic floor.”

Unfortunately, and in light of the publication of many similar studies showing the danger of transvaginal mesh, the many TVM product manufacturers have failed to warn women of the risks associated with their products. Because of this, a number of vaginal mesh lawsuits have been filed.

Vaginal mesh in pelvic floor reconstruction has become more and more popular, and this is partially due to the high failure rates associated with older methods. In an article titled “Rising Use of Synthetic Mesh in Transvaginal Pelvic Reconstructive Surgery: A Review of the Risk of Vaginal Erosion”, written by the Department of Gynecology and Obstetrics, at The University of Genova, in Genova Italy, author Emanuela Mistrangelo claims, “Recently, the use of surgical mesh in pelvic floor surgery has become increasingly popular. While the reduction of surgical failure rates in vaginal reconstructive surgery is of critical importance, the addition of graft materials must be shown to improve anatomical outcomes and at least maintain, if not improve, lower urinary tract, bowel, and sexual function, as well as quality of life for the patient.

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Synthetic materials still have several disadvantages including vaginal erosion. Several factors contribute to the wide range of vaginal erosion rates, including patient characteristics such as age and estrogen deficiency; operative technique; implant size; and the specific properties of the graft material, such as pore size, stiffness, elasticity, and basic tissue compatibility. It is the aim of this article to present a critical review of the risk of vaginal erosion with use of synthetic grafts during vaginal reconstructive surgery.”

The use of synthetic prostheses have been used since the late 19th century, and the use of prosthetic materials for gynecologic surgery has been seen since the 1980’s. Ulmsten and Petros were the two primarily responsible for the use of synthetic tape. Synthetic slings have become increasingly popular in the management of urinary incontinence.

Mistrangelo further explains, “ Synthetic materials obviate the need for harvesting autologous tissues and are associated with high success rates, but they have several disadvantages such as risk of infection and vaginal-urethral erosion/extrusion. Several factors contribute to the wide range of erosion/extrusion rates, including operative technique, implant size, and the specific properties of the sling material, such as pore size, stiffness, elasticity, and basic tissue compatibility. Understanding the classification, mechanical properties, and host-graft interaction for synthetic prostheses is essential for the rational choice of material for prolapse and incontinence surgery.”

The authors also note that many studies have shown that about 50 percent of women around the age of 70 will need some sort of correctional surgery regarding POP, and while some studies have shown a decreased failure rate with the newer methods to treat organ prolapse, there are significant risks involved with any type of treatment, and all surgery carries inherent risk.

Due to the fact that many TVM manufacturers have failed to notify women of the risk for TVM complications, vaginal mesh lawsuits have been filed around the world in great number. If you or a loved one used TVM and experienced a TVM complication, you may be entitled to significant financial compensation for your injury from the manufacturer of your TVM product by means of a TVM lawsuit.

For more information or a free, no-obligation case consultation, contact our team of transvaginal mesh lawyers at the information provided below.

In the United States alone, over 300,000 pelvic floor reconstructions and urinary incontinence are performed. Around 29 percent of these surgeries are reoperations. The high failure rate of older methods gave way to the development of vaginal mesh kits in 2005. Mesh-augmented vaginal prolapse repairs have shown to improve anatomical outcomes and are associated with low levels of recurrence rates. However, the risk for significant complications are still pretty high: 2,874 complications associated with surgical mesh operations were reported from 2008 to 2010, as reported by the Food and Drug Administration. 50 percent of the 2,874 complications reported had to do with prolapse repairs. TVM complications from vaginal mesh repair can have a significantly negative impact on a patients quality of life. Many times, surgery is the only course of action that can correct the problem.

The objective of a study called “Recurrence of Prolapse After Transvaginal Mesh Excision”, published by the Division of Female Pelvic Medicine & Reconstructive Surgery at the Department of Obstetrics and Gynecology at Indiana University Health in Indianapolis, IN was to evaluate the anatomical and functional outcomes before and after surgery in patients undergoing mesh excision, and the study was a retrospective cohort analysis of patients who underwent mesh excision. The POP quantification was used to evaluate the anatomical outcomes. For the study, recurrence of prolapse was defined as stage II or higher-stage prolapse, reoperation for prolapse, or situations requiring “postoperative use of a pessary for prolapse reduction.” The pelvic floor distress inventory was used when assessing the functional outcomes.

Author Amy George from the above article explains the results “Data were analyzed from 71 patients who underwent either partial or complete mesh excision. Most (44/70 [63%]) of the patients underwent partial mesh excision, and 26 patients (37%) underwent total mesh removal. Nineteen patients (26.7%) had preoperative prolapsed and 27 (38.0%) of the 71 patients underwent concomitant native tissue prolapse repair. Overall change in POP-Q stage in women who underwent partial removal (median, 0 [j1 to 2]) was less advanced than in women with total excision. (median, j1 [j3 to 0]; P = 0.006) at 1 year postoperatively. Four patients prolapsed to the hymen, with all patients having defects in the anterior compartment. No patients required a second surgery, and one patient was treated with a pessary. Total pelvic floor distress inventory and pelvic floor impact questionnaire scores before mesh excision were significantly improved 6 months after mesh removal (P G 0.05). Dyspareunia improved significantly after mesh excision (P = 0.034).” Partial and total mesh excision was concluded to be associated with re-treatment of POP in 1.4 percent of the patients, and functional outcomes were significantly improved after mesh removal.

There are many risks involved with re-operation after pelvic floor reconstruction. Older methods used to treat organ prolapsed repair were associated with high rates of failure, hence newer, more safe methods such as the use of synthetic materials are being used to augment pelvic organ prolapse repair. In a report titled “Review of Synthetic Mesh-Related Complications in Pelvic Floor Reconstructive Surgery” written by the Department of Obstetrics and Gynaecology, Derby City General Hospital, Author Abdulmalik Bako claims “The use of synthetic mesh to correct apical, anterior and posterior vaginal wall prolapse is not without complications. This review aims to evaluate the long-term complications of synthetic mesh in pelvic reconstructive surgery. Some studies suggest that about 50 percent of parous women have some degree of pelvic organ prolapse. Ten percent of these cases being symptomatic. Women around the age of 80 have an 11-12 percent risk of surgery for prolapse. There are several surgical procedures that have been created to correct pelvic organ prolapse (POP). All of these surgeries are associated with their own high levels of failure, despite increasing knowledge of pelvic anatomy and improvements in surgical techniques.

Author Abdulmalik Bako continues with “A re-operation rate of nearly 30% has been reported [2, 5]. Some studies quote a recurrence risk as high as 33–45% [6, 7]. Traditional surgical procedures can take a long time to perform, result in long hospital stay, long time to recover and return to daily activities [8] resulting in higher cost to the health service and the society. The need to improve the outcome of traditional surgical treatment of pelvic organ prolapse has led to increased use of graft materials in pelvic reconstructive surgery. The aim of using mesh in pelvic reconstructive surgery is to result in repairs that are safe, effective and durable. Whilst on the one hand, sub-urethral sling procedures using synthetic meshes are now the gold standard for the surgical management of stress urinary incontinence with a success rate of around 81% at 7-year follow-up [9].”

There is still insufficient data to make any definitive conclusions with regard to effectiveness of biological or synthetic materials in primary or recurrent prolapse surgery. Abdulmalik Bako further states, “The objective of using mesh in pelvic reconstructive surgery includes: substitution or replacement of lacking supportive tissue, reinforcement of weak or defective supportive tissues or induction of new supportive tissue and consolidation to complement traditional surgical techniques[3]. It is important to note that the use of synthetic mesh is not without complications and mesh-related complications could have significant impact on the quality of life of sufferers.”

Articles such as this can be used as evidence in a transvaginal mesh lawsuit to demonstrate that TVM manufacturers knew or should have known the risks associated with the use of their products, and because many of these companies have time and again failed to make this information public, a number of transvaginal mesh lawsuits have been filed around the world.

If you or a loved one used a vaginal mesh product and experienced a vaginal mesh complication, please do not hesitate to contact our team contact our team of transvaginal mesh lawyers at the information provided below.

In 2011, the International Urogynecological Association published a study called “Prospective Study of Anterior Transobturator Mesh Kit for the Management of Recurrent Anterior Vaginal Wall Prolapse”, where the objective was the assessment of the 2 year outcome of anterior Prolift for patients with recurrent anterior vaginal wall prolapse. Anterior wall repair is a procedure that tightens the front wall of the vagina when it shifts or moves out of place. Author Abdalla M. Fayyad states that “This is a prospective study which was conducted in a tertiary unit in the North West of England and comprised 36 consecutive women with recurrent anterior vaginal wall prolapse.
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Women were assessed preoperatively and postoperatively at 6 months and 2 years. Women completed the Prolapse Quality of Life Questionnaire (P-QOL), Prolapse and Incontinence Sexual Function Questionnaire-Short Form (PISQ-12), and postoperatively, the Global Impression of Improvement Questionnaire. Women were examined using the Pelvic Organ Prolapse Quantification System (POP-Q).” Success on the anatomical level, were defined as stage 1 or less in the anterior compartment. A follow-up evaluation was done after about two years that found 19 women had stage 1 or less anterior wall prolapse, 2 women had stage 3 prolapse, and 15 women had stage 2 anterior wall prolapse. While twenty-nine patients reported improvements in their symptoms, sixteen women were sexually active preoperatively, of whom seven reported worsening dyspareunia (pain or suffering during sexual intercourse).

Abdalla M. Fayyad further explains “Surgical treatment of pelvic organ prolapse has seen a proliferation in techniques and graft materials that are intended to improve surgical outcome and reduce the recurrence rate. Vaginal repair with mesh kits has recently been introduced [3]. There is paucity of data on the medium- and long-term outcomes and complications related to these surgical kits. Jacquetin and Cosson reported the importance of a systemic approach in the assessment of outcomes and complications following mesh kit repairs for prolapse”. (external link added)

More research needs to be done to have a complete understanding of the risks involved with the newer procedures. The National Institute of Health and Clinical Excellence recommends’ all women undergoing repair of prolapse using mesh, should have in depth pre-and postoperative assessments.

Since many transvaginal mesh (TVM) manufacturers have failed to warn women of the risk for vaginal mesh erosion and vaginal mesh failure, transvaginal mesh lawsuits have been filed around the country. If your or a loved one used transvaginal mesh and suffered vaginal mesh failure or vaginal mesh erosion, please do not hesitate to contact our team of vaginal mesh lawyers for a free, no-obligation case consultation.

We have the experience, resources, and skills required to win the justice you deserve.

The objective of a study called “Outcomes and Predictors of Failure of Trocarguided Vaginal Mesh Surgery for Pelvic Organ Prolapse”, written by the department of Obstetrics and Gynecology, Reinier de Graaf Group, and the Department of Obstetrics and Gynecology at Radboud University Nijmegen Medical Centre in Nijmegen, The Netherlands, was to compare the outcomes of trocar-guided vaginal mesh surgery and identify predictors of failure. Trocar refers to a sharp pointed instrument used to puncture the wall of a body cavity and withdraw fluid. Failure outcomes were defined as prolapsed stage 2 or greater, overall prolapsed sage 2 or greater, and composite outcome of over prolapse greater than the hymen and the presence of bulge symptoms or repeat surgery.

Author Alfredo L. from the above study explains the results “The results of the study were 1 year follow-up of 433 patients. Treated compartment failure (I) was 15% (95% confidence interval [CI], 12–19). Overall prolapse failure (II) was 41% (95% CI, 36–45). Composite failure (III) was 9% (95% CI, 7–13). Predictor of failure in all outcomes was the combined anterior/posterior mesh with the uterus in situ.” It was found that combined anterior/posterior mesh insertion with the uterus in situ were consistent factors for failure. Around 50 percent of women who bear multiple offspring may develop pelvic organ prolapse (POP). It has been reported that the general population of females to the age of 85 have a 20 percent risk of undergoing surgery for POP, and increased use of prosthetic mesh in vaginal prolapse surgery is partially from the high risk involved with failure rates for native tissue repair.

The National Institutes of Health Workshop on Standardization of Terminology for Researchers in Pelvic Floor Disorders have proposed strict anatomic outcome criteria that have been used for most studies done on the subject of vaginal mesh surgery for pelvic organ prolapse. Some studies suggest a relationship between postoperative absence of vaginal bulge symptoms and the patient’s assessment of their overall improvement. Many researches recommend that future definitions regarding POP success should include complete absence of bulge symptoms.

Since so many vaginal mesh kits are shown by medical research teams from all over the world to have a high rate of failure, vaginal mesh lawsuits have been filed in great numbers. If you or a loved one experienced the dangerous potential complications of vaginal mesh, you may be entitled to significant financial compensation.

For a free consultation, contact our team of vaginal mesh lawyers. We have the experience and resources to bring you the justice you deserve.

In 2004, the FDA cleared the use of synthetic vaginal mesh delivery systems. The high failure rates from traditional vaginal colporrhaphy and apical suspension procedures using native tissue is what gave way for the development of the new mesh method. Familiarity for surgeons with the transobturator region increased as a result of the deployment of transobturator slings. This increased familiarity gave way to the development of vaginal synthetic mesh transobturator delivery systems for pelvic organ prolapse repair.

Some complications of vaginal mesh are asymptomatic and may involve minimal intervention for correction. Other more rare, but life-threatening complications include severe vascular injury, severe pelvic pain, or visceral injury resulting in abscess formation.

Author Cheryl B. Iglesia, from the Section of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology and Urology, Georgetown University School of Medicine/Washington Hospital Center, Washington, District of Columbia, wrote a report titled “Synthetic Vaginal Mesh for Pelvic Organ Prolapse”. The purpose of the review was to summarize comparative trials on synthetic vaginal mesh, compared to traditional native tissue repairs for pelvic organ prolapse. Cheryl B. Iglesia states “Although studies suggest benefit from the use of synthetic vaginal mesh for anterior compartment prolapse, data are limited on the use of mesh for posterior and apical prolapse when compared with native tissue repair.

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The benefits of a more durable repair must be weighed against risks such as the development of de-novo stress incontinence, visceral injury, dyspareunia, pelvic pain and mesh contraction, exposure and extrusion requiring reoperation. Furthermore, the success rates of native tissue repairs are higher than previously considered using updated validated composite outcomes that incorporate both subjective relief of bulge and objective cure defined as prolapse above the hymenal ring.”

Since so many scientific articles have been published like this one that show the danger and inefficacy of TVM, and many manufacturers of TVM do not make these risks clear to patients, a number of transvaginal mesh lawsuits have been filed around the world.

For a free transvaginal mesh lawsuit consultation, contact our team of vaginal mesh lawyers at the information provided below. We have the experience, resources, and skills required to win the justice you deserve.

Pelvic organ prolapse (POP) is a major health issue, especially concerning to older women. Women who have had multiple children have a 50 percent chance they will one day need corrective surgery, and recurrence rates as high as 70 percent have been seen after traditional vaginal prolapse surgery. This has caused many doctors to recommend vaginal mesh for the treatment of POP. There are both pros and cons to the new method of treatment involving mesh in vaginal prolapse surgery. Not many randomized controlled trials have been published on this subject, but from the information available, improved anatomic outcomes and lower recurrence rates have been shown. Exposure of the mesh into the vagina, bladder, or bowels are the main mesh-related complications. Author M. Myrthe from the International Urogynecol Journal, conducted a study called “Surgical Management of Mesh-related complications After Prior Pelvic Floor Reconstructive Surgery with Mesh”, where it is stated “The objective of this study is to evaluate the complications and anatomical and functional outcomes of the surgical treatment of mesh-related [complications].” The above study was a retrospective cohort study of people had partial mesh excision to treat complications from pelvic floor reconstructive surgery.

Dr. Myrthe continues with the explanation of the results, “Seventy-three patients underwent 30 complete and 51 partial mesh excisions. Intraoperative complications occurred in 4 cases, postoperative complications in 13. Symptom relief was achieved in 92% of patients. Recurrence of pelvic organ prolapse (POP) occurred in 29% of complete and 5% of partial excisions of mesh used in POP surgery. [New] stress urinary incontinence (SUI) occurred in 36% of patients who underwent excision of a suburethral sling.”

Over the past 20 years, the use of mesh for correction of sphincteric abnormalities has greatly increased. High success rates and simpler surgical techniques have helped its overall appeal. Recently, there has been mounting concern over potential complications with this new procedure. 4,000 reports of TVM complications were submitted to the FDA by 2010-average of 958 cases per year. Pelvic pain, vaginal mesh erosion, urinary tract infections, and organ perforation were some of the most frequent complications during this timeframe. The most experienced doctors have trouble with management of mesh sling complications. A study titled “Salvage Surgery After Failed Treatment of Synthetic Mesh Sling Complications”, published in the Journal of Urology, claims the purpose of the study was to report their experience with the diagnosis and treatment of refractory synthetic sling complications in women. Author Jerry G. Blaivas from the above study states “This is a retrospective study of consecutive women with failed treatments for mesh slingcomplications. Pre‐ and postoperatively, patients completed validated questionnaires, voiding‐diaries, uroflow with post‐void residuals, pad‐test, cystourethroscopy and videourodynamic studies.”

Results from the study were divided into two groups-conditions and symptoms. The Patient Global Impression of Improvement was used to assess the patient’s improvement. Author Jerry G. further explains his results, “Forty‐seven women, aged 35‐83 years (mean=60) had undergone at least 1 prior operation (range: 1‐4) to correct sling complications. Original sling composition was Type‐1 mesh in36 patients and Types‐2 and 3 in 11. Surgical procedures included sling incision, sling excision, urethrolysis, urethral reconstruction, ureteroneocystotomy, cystectomy & urinary diversion, and enterocystoplasty. Median follow‐up was 2 years (range: 0.25 ‐ 12, mean=3).” A successful outcome was reported by 72 percent of the patients.

Multiple surgeries may be required after an initial failure to repair mesh sling complications, and this article concludes that surgical success with TVM is possible. Due to the high rate of failure associated with transvaginal mesh, however, a number of TVM lawsuits have been filed around the world.

If you used TVM and experienced dangerous complications of vaginal mesh, you may be entitled to significant financial compensation for your injury. At your convenience, you may contact our team of transvaginal mesh lawyers for a free consultation at the information provided below.

It is estimated that 300,000 pelvic organ prolapse related surgeries are performed in the United States every year. Pelvic organ prolapse is a global wide health issue for women. High failure rates are seen with anterior surgical repair of cystocele or anterior wall prolapse. These procedures may constrict and impair vaginal anatomy. Some doctors recommend that paravaginal repairs should be performed abdominally or laparoscopically for providing sounder anatomic support. New methods for treating anterior vaginal prolapse have been created, showing to have higher cure rates than traditional methods. These new methods require complex dissections and surgical techniques which may come with their own complications. Author Robert D. Moore, from the International Urogynecological Association, wrote an article called “Prospective Multicenter Trial assessing type 1, Polypropylene Mesh placed Via Transobuturator Route for the Treatment of Anterior Vaginal Prolapse”, where he states that “The use of synthetic mesh is considered the gold standard for treatment of vault prolapse abdominally with sacral colpopexy [4]. More recently, grafts have been used vaginally to treat prolapse, including the anterior compartment, in attempts to try to reproduce the success that mesh has been shown to have with sacral colpopexy. Various methods have been described and most have been shown to have higher cure rates than traditional repairs.”

A review written by A. Cochrane in 2008, supports the use of mesh graft in the anterior compartments. The review reported a higher rate of recurrent prolapse after anterior colporrhaphy than after mesh repair. Robert D. Moore continues to explain “The transobturator space has been shown to be a safe space for the placement of tension-free tape slings for the treatment of stress urinary incontinence and has simplified the technique of this procedure [7, 8]. The space has also been more recently used to assist with anterior wall mesh placement. De Tayrac was the first to describe its use in cystocele repair by securing the anterior arms of a tension free graft; however, no apical attachment of the graft was described.” The Perigee System, a minimally invasive treatment option, was created to place an anterior wall graft for cystocele repair.

Some studies suggest an 18-month cure rate for 93.5 percent of the patient’s using this procedure, which is OK but not sufficient, given that around 50 percent of women who have multiple children may develop pelvic organ prolapse.

In light of all the research showing the danger of transvaginal mesh, many manufacturers of TVM products have failed to notify customers of the risks associated with their products. And as such, transvaginal mesh lawsuits have been filed around the world.

About this Blog

This blog chronicles legal and scientific news relating to personal injuries caused by defective drugs and medical devices. It is published by injury lawyer Justinian C. Lane, an attorney who takes a personal interest in each of his clients’ cases.